Intro to Quality Management Week 3
Air Bag Recall
Assignment
Review the article Blow Out from this weeks reading assignment. This article pertains to the recall of air bag products. Assume you are the manager for a large automotive company that will be using air bags in your products. What risk assessment tools will you use in order to ensure that the product being installed into your vehicles meets safety standards in order to avoid a recall? Use your course materials and outside research to generate a solid analysis on why these methods would be helpful. Your analysis should be supported by research.
Directions for obtaining the file: Login to the Grantham University library by clicking on the Resources tab from the main page. You will then log into EBSCOHost. Once you have accessed the database simply copy and paste the title of the article and press enter to search and you should now have the file accessible to review.
The requirements below must be met for your paper to be accepted and graded:
Write between 750 1250 words (approximately 3 5 pages) using Microsoft Word in APA style see example below.
Use font size 12 and 1 margins.
Include cover page and reference page.
At least 80% of your paper must be original content/writing.
No more than 20% of your content/information may come from references.
Use at least three references from outside the course material one reference must be from EBSCOhost. Text book lectures and other materials in the course may be used but are not counted toward the three reference requirement.
Cite all reference material (data dates graphs quotes paraphrased words values etc.) in the paper and list on a reference page in APA style.
Article
Section:
Features
Business: Cars
Keywords: Safety; Automotive industry; Driving; Accidents; Brain; Congress; Design; Regulations; Vehicles; Weight; Fariello; Cars
Air bags are meant to save lives. Now a massive recall shows how they sometimes can turn deadly
Forensic Investigator Sal Fariello whose job is to deconstruct car crashes has witnessed a catalog of carnage caused by air bags over the past two decades. In his collection there is a photo of a woman who has been horribly scarred by an inflating air bag. There’s an X-ray of a driver’s broken wrists snapped in the fling zone of an air bag that mashed both arms from a 10-and-2 position into the car’s roof. He can cite numerous drivers who suffered torn aortas or lacerated brain stems all the result of being punched by an air bag inflating at 200 m.p.h. (322 km/h). What’s sitting in the front of the steering wheel is an explosive device explains Fariello the author of Airbag Injuries: Causation & Federal Regulation. Nasty unexpected events can occur.
None have been nastier than the injuries and deaths caused by exploding inflators in air bags made by automotive supplier Takata Corp. based in Tokyo. Its air bags have been blamed for killing five motorists in the U.S. so far. More than 10 million cars from 10 makersincluding BMW Chrysler Honda Nissan and Toyotahave been recalled. On Nov. 26 the National Highway Traffic Safety Administration (NHTSA) ordered Takata to expand its most recent recall from a regional one to a national one. Takata declined on the basis that the problem is confined to areas like Florida with high relative humidity. Toyota and Honda are following NHTSA’s advice and issued a national recall. All the cars are from model year 2011 or older.
Takata’s suspect inflation canisters contain a propellanttablets of ammonium nitratethat is ignited at the onset of a crash to initiate a chemical reaction that produces nitrogen gas to fill the bag. Moisture may be destabilizing the ammonium nitrate. In the faulty inflators the blast shatters the canister sending metal shards through the air bag toward the driver. Arriving at the scene of one such incident police thought the victim had been shot in the face before crashing. My understanding is our products in this accident worked abnormally said Hiroshi Shimizu who is in charge of Takata’s global quality assurance when prodded by Nevada Senator Dean Heller during Senate-committee testimony on Nov. 20.
On Dec. 2 Toyota called for a joint industry initiative to independently test the Takata bags. The safety security and peace of mind for our customers are our highest priority and I believe this is shared with all the other automakers said Simon Nagata CEO of Toyota’s North American manufacturing unit.
Perhaps these scenesaccident reports detailing both gore and tragedy congressional hearings well stocked with outrage and executives who struggle for the right tone of responseshould come as no surprise. It has after all been a very bad year for the auto industry. General Motors’ recall of 2.6 million vehicles earlier in 2014 stemmed in part from defects that led to air bags’ not deploying at all causing injury and death.
But the Takata crisis once again reminds us that this foundational piece of auto safety equipment has always carried the risk of injuryand deathriding shotgun. People have been hurt because they are the wrong size shape or age to get the optimal benefit from a device first designed for an average male. And now in Takata’s case because of a defect.
How Did We Get Here?
An air bag in deployment has to first measureand then counterthe considerable inertial forces that are brought to bear when your car crashes into another vehicle or object. In a collision your car stops abruptly but you don’t. Your head and body keep moving forward translating that energy according to Newtonian physics until some other force arrests it. Before the advent of air bags and seat belts this velocity debt was repaidat terrible costwhen your head or body smashed into the steering column or dashboard.
To stop your head’s violent forward motion requires considerable counterviolence. After a car’s accelerometers and sensors detect a crash pulsethe rapid deceleration that signals impactan algorithm in the electronic control unit (ECU) then decides whether to deploy the air bag and at what pressure. If the ECU says deploy the explosion that rapidly expands an air bag also hurtles it toward your head at speeds ranging from 98 m.p.h. to 200 m.p.h. (158 km/h to 322 km/h). In fact the bag should be deflating by the time your head makes contact creating a cushioning force that dissipates the energy of the crash by distributing it over the larger surface area of the bag. The entire process of sensing and deploying the air bag has to take place in 20 to 30 milliseconds by which time your head has already moved forward five inches.
Air bags have been saving lives since 1973 when General Motors produced 1000 Chevrolet Impalas equipped with air bags as an option. According to Byron Bloch an auto-safety expert who has long campaigned for better air bags Chevy produced a good one: a dual-pressure system that protected children from a fully powered air bag’s potentially lethal force. GM was satisfied with the technologythe concept was patented in 1953and Bloch said the company was ready to expand the program. We were going to have dual-pressure air bags phased in the ’74’75 model year he says.
Instead air bags disappeared for nearly 20 years. Why? The Big Three auto companies led by Ford boss Henry Ford II and his deputy Lee Iacocca convinced President Richard Nixon that air bags wouldn’t be cost-effective. The pressure on the Big Three to offer air bags ultimately came from smaller competitors like Volvo that made air bags standard equipment. With consumers clamoring for protection Congress made air bags mandatory as of September 1998.
The design and testing standards of these late-1990s air bags however would not make them better than the ones GM used in the early 1970s. When two elderly women were killed by air bags in the early ’90s it was a lethal indication that there were flaws. The elderly die very easily in car crashes says Fariello who has been a paid expert witness for both plaintiffs and defendants in injury lawsuits. The force of the deployed air bag even in low-speed fender benders was causing fatal chest and brain injuries. Short women were being injured because they moved their seats forward to reach the gas and brake pedals. As a result their faces were within 10 in. of the steering wheel which experts say is the minimum safety margin.
Auto-industry safety organizations consumer groups the Society of Automotive Engineers NHTSA and the Insurance Institute for Highway Safety have debated test conditions for decades. NHTSA’s frontal tests are run at 35 m.p.h. (56 km/h) into a rigid barrier using a crash-test dummy optimized for a 50th-percentile maleabout 172 lb. and 5 ft. 9 in. (78 kg and 175 cm). Yet most crashes happen at speeds below 35 m.p.h. and they involve all kinds of people objects and crash angles. Hitting a pole is different from hitting a wall or another vehicle.
The test method meant that passengers who weren’t perfectly average were out of position in the vernacular of crash analysis. If you are not a 50th-percentile male something else happens says Fariello. Something very bad it turned out happens to women and children. According to NHTSA’s data air bags killed 191 children from 1990 to 2009 as well as 39 women who were 5 ft. 2 in. (157 cm) or shorter.
In the real world crashes occur in all different directions but we still need some standard test procedures to design around. The question is What proportion of real-world crashes have you covered? says Priya Prasad a safety consultant and expert in injury biomechanics who was formerly Ford’s top safety scientist. It would take several years of debate before NHTSA added a fifth-percentile female crash dummy to the test.
There’s no question that air bags can and do save lives especially in combination with advanced seat belts. But frontal-air-bag performance hasn’t changed significantly in recent years says Professor Richard Kent. He is deputy director of the Center for Applied Biomechanics at the University of Virginia which does testing for the government and other institutions. The adoption of advanced air bags that depower in low-speed crashes mandatory since 2006 and moving kids out of the front seat and into backseat restraints marked the last big survivability improvements. As far as injury effectiveness there’s no reason to think it’s substantially different than what it was five years ago he says.
How Good Are Air Bags Anyway?
But the bottom line on air bags is that their contribution to an accident’s survivability has always been incremental. Seat belts are the first and most important line of defense. Studies show that if you wear a seat belt you have about a 45% greater chance of surviving a potentially lethal crash. Adding an air bag improves that figure to 50% with a margin for error in both cases. According to NHTSA frontal air bags saved 2213 lives in 2012 but seat belts saved 12174 lives more than five times as many. Keep in mind that 33561 highway deaths were recorded in 2012. If you crash at a high speed and aren’t wearing a seat belt having an air bag in the car is as useful as having a balloon.
Can air bags get better? In my opinion air-bag technology is mature. It has sort of done what it is supposed to do says Kent. There’s more promise in advances elsewhere. Electronic stability control for instance is reducing rollovers which are particularly lethal. More advanced seat belts and sensors offer even more possibilities. By sensing the weight and position of occupants and whether they are belted belts work with air bags first to pretension (that is tighten) the shoulder strap and then let it unspool to apply the minimum force needed to restrain passengers without injuring their ribs or thorax with the air bag arriving to cushion the head. That’s particularly important for the increasing number of older drivers who suffer a disproportionate number of chest injuries.
It might be possible says Prasad to move to a smarter three-stage air-bag system. More likely he says is that black-box data recorders now in every car combined with newer anticollision warning and braking systems will improve the margin of safety. You will be able to predict what type of crash. And once you start predicting you could fire an air bag before the crash. Ultimately self-driving cars may render the whole driver-safety issue moot. But that could take a decade or even two.
In the meantime there are still a lot of old cars out there. Fariello recommends that you follow the New York State transportation department’s advice and hold the wheel in the 9 and 3 o’clock position as opposed to the 10 and 2 that many people were taught. If you are short consider pedal extenders to keep your face at least 10 in. (25 cm) from the wheel. And as far as car sizes go in a collision big beats small. Newton’s laws won’t have it any other way.
Fariello Bloch and others are concerned that overweight people still face greater danger. Current testing hasn’t accounted for them. According to Humanetics a company that makes crash-test dummies obese people are 78% more likely to die in crashes than average-weight people. The company is developing a test dummy that is 273 lb. (124 kg) with a body mass index of 35.
There is no precaution that protects you if your air bag becomes a weapon as has happened in some of the Takata incidents. Bloch a longtime advocate for safer air bags believes carmakers should disclose the air-bag supplier for each model. Some inflate in a basketball shape while others are pillow shaped which is better. Some have tethers that limit the distance they can travel which is potentially less damaging.
Amid all this sobering news it’s worth noting that the death rate on U.S. roads is decliningit has fallen 23% since 2005 and should decrease again this yearand seat-belt usage is at a record high. We’re a lot saferand will be even more so when the defective air bags are fixed.
HOW AIR BAGS WORK
THEY DEPLOY ONLY IN CERTAIN CRASH CONDITIONS. DEFECTS CAN HARM THE VEHICLE’S OCCUPANTS
[This article consists of 3 illustrations. Please see hardcopy of magazine or PDF.]
IMPACT
Sensors in your car detect the pulse of impact as well as the position of occupants sending signals to the electronic control unit in the middle of the car. An algorithm decides whether to deploy the air bags and at what forcefull or partial power.
PROPELLANT
STEERING COLUMN
FOLDED AIR BAG
IGNITER
INFLATOR
DEPLOYMENT
Air-bag inflators are small metal containers that hold an igniter and a propellant. In a crash the ignited propellant triggers a chemical reaction that produces nitrogen gas which fills the bag rapidly.
NITROGEN GAS
WHAT GOES WRONG
Takata’s propellant ammonium nitrate tablets may be degrading over time particularly in humid climates. This could cause a violent reaction in a crash in which the force blasts apart the inflator causing injuries or death.
814 M.P.H.
Minimum crash speed (1323 km/h) that could cause an air bag to deploy
2213
Lives saved by air bags in the U.S. in 2012
AFTER A CRASH IT TAKES:
0.02 SECONDS
for an air bag to deploy
0.06 SECONDS
for the passenger to hit the air bag
Intro to Quality Week 2
Product Recall
Review the article USPlabs Recalls OxyElite Pro Supplements Amid Links to Liver Illness which can be found in your weekly reading. This article pertains to a recall of a popular health supplement. Assume you are the manager for the OxyElite Pro supplement. How can you use focus groups and surveys to determine your customers feelings about their products despite the recall that has occurred? Use your course materials and outside research to generate a solid analysis on why these methods would be helpful. Your analysis should be supported by research.
READING
USPlabs Recalls OxyElite Pro
Supplements Amid Links
to Liver Illness
Dallas TX-based USPlabs LLC has recalled
certain OxyElite Pro dietary supplement
products that the company markets after
receiving a letter from FDA stating that the
products have been linked to liver illnesses
and that there is a reasonable probability
that the products are adulterated.
The letter also notifi ed USPlabs that if
the company did not initiate a voluntary
recall FDA could by law order the company
to immediately stop distributing the
products and immediately notify other
parties to stop distributing the supplements.
The action marks the second time
the FDA has exercised its recall authority
under the FDA Food Safety Modernization
Act (FSMA) by sending such a letter.
We took this step to ensure that adulterated
and harmful products do not reach
the American public said Deputy Commissioner
for Foods and Veterinary Medicine
Michael Taylor. We will continue to
work with our state industry and regulatory
partners to prevent such products
from reaching the public.
By letter dated Nov. 6 the FDA notifi ed
USPlabs about fi ndings indicating a link
between the use of several OxyElite Pro
products and a number of liver illnesses
reported in Hawaii. The FDA also noted
that cases of liver damage after use of these
OxyElite Pro products had been found in
a number of other states. In a review of 46
medical records submitted to the FDA by
the Hawaii Department of Health the records
indicated that 27 patients or 58%
had taken a dietary supplement labeled as
OxyElite Pro prior to becoming ill. Seventeen
of the 27 patients (or 63%) reported
that OxyElite Pro was the only dietary
supplement they were taking. At least one
death has occurred among these patients
and others required liver transplant.
In a warning letter issued to USPlabs
LLC on Oct. 11 2013 the FDA informed
the company that OxyElite Pro and another
dietary supplement called VERSA-1
were deemed to be adulterated. The products
contained aegeline a new dietary ingredient
(i.e. an ingredient not marketed
in the U.S. before Oct. 15 1994) that lacks
We will continue to work with our state
industry and regulatory partners to prevent
such products from reaching the public.
Michael Taylor FDA on USPlabs recall
Global Sales of Non-GMO Food and
Beverages to Reach $800 Billion by 2017
Non-GMO products will account for about 15% of total
global food and beverage sales.
Global sales of non-GMO food and beverages are projected to rise
to $800 billion by 2017 at a compound annual growth rate (CAGR) of
15% and will account for about 15% of total global food and beverage
sales at that point according to Packaged Facts recently released
report Non-GMO Foods: Global Market Perspective. Global
sales of non-GMO products reached $400 billion in 2012 accounting
for 8% of the overall global food and beverage sales of $5 trillion.
Excluding the U.S. and Canada Packaged Facts identifi ed 10
countries that represent as much as two-thirds of the new global non-
GMO product introductions from 2009-2013. Russia is the leader with
15% share followed by the U.K. with a share of 10%. From a comprehensive
global perspective the U.S. share is roughly 40%. Aside from
the U.S. and Canada Europe represents seven in 10 global non-GMO
food and beverage rollouts between 2009 and 2013. Europe is followed
at a considerable distance by Asia and Oceania.
Packaged Facts projected that non-GMO sales will increase in
all regions of the globe as will the practice of labeling foods and
beverages with non-GMO verifi ed or certifi ed labels. Prompting
increases will be the inevitable expansion of GMO crops into territories
where they had previously been banned or limited. Concerned
shoppers will want GMO and non-GMO labeling to help
them distinguish between the two types of products. The BRIC
nationsBrazil Russia India and Chinawill be fertile territory for
non-GMO sales as their emerging middle classes look for healthier
eating options according to David Sprinkle research director for
Packaged Facts.
As other nations seek to clarify the labeling of their products
both GMO and non-GMO Packaged Facts projected the portion
of the global non-GMO market represented by sales in the U.S.
will decline through 2017. In addition non-GMO labeling will become
more available as certifi ed testing operations like NSF International
join Cert ID in the non-GMO verifi cation market to take
advantage of a growing demand from marketers.
Non-GMO labeling will become more available as
certifi ed testing operations
join the verifi cation market.
16-31IndustryNews1213.indd 16 11/26/13 3:40 PM
Industry News
18 Nutraceuticals World www.nutraceuticalsworld.com December 2013
a history of use or other evidence of safety.
The letter stated that failure to immediately
cease distribution of all dietary supplements
containing aegeline may result in
enforcement action.
U.S. Marshals Seize
Adulterated Supplements
Worth More Than $2 Million
At the request of FDA U.S. Marshals
seized dietary supplements manufactured
and held by Hi-Tech Pharmaceuticals Inc.
located in Norcross GA after agency investigators
found the products contained
1 3-Dimethylamylamine HCl (DMAA) or
its chemical equivalent in early November.
The retail value of the seized products is
more than $2 million.
A complaint fi led in the U.S. District
Court for the Northern District of Georgia
alleged that the products were adulterated
according to the Federal Food Drug
and Cosmetic Act because they contain
DMAA an unapproved food additive that
is deemed unsafe under the law.
DMAA can elevate blood pressure and
could lead to cardiovascular problems including
heart attack shortness of breath
and tightening of the chest. Given the
known biological activity of DMAA the
ingredient may be particularly dangerous
when used with caffeine. The FDA has
warned consumers about the health risks
of DMAA on its website.
On Nov. 12 U.S. Marshals seized more
than 1500 cases of fi nished goods and
more than 1200 pounds of in-process/raw
material goods from the Hi-Tech Pharmaceuticals
Inc. facility.
This company has a responsibility to
ensure its products are safe for distribution
and human consumption said Melinda
Plaisier the FDAs associate commissioner
for regulatory affairs. We have taken action
to protect consumers and demon-
Trade Groups Defend Supplement Use
Following Multivitamin Review
Meta-analysis concludes more research needed on use of
vitamin/mineral supplements for CVD and cancer prevention.
A systematic review of published studies
found insuffi cient evidence that vitamin and
mineral supplements are effective for preventing
cardiovascular disease (CVD) cancer
or mortality from those diseases in healthy
adults according to an article published in
Annals of Internal Medicine.
Two studies included in the review found
lower overall cancer incidence in men who
took a multivitamin for more than 10 years.
Those same studies showed no cancer protection benefi t for women.
Researchers cautioned that more research is needed before it
can be determined whether or not multivitamin supplementation
is benefi cial.
The evidence review was conducted by researchers for the U.S.
Preventive Services Task Force (USPSTF) to update its previous recommendation.
In 2003 the USPSTF found insuffi cient evidence to
recommend for or against the use of vitamins A C and E multivitamins
with folic acid or antioxidant combinations for the prevention
of CVD or cancer. At the time the USPSTF recommended against
beta-carotene supplements alone or in combination with other supplements
because they had no benefi t and actually harmed patients
at risk for lung cancer. The current research review reconfi rmed the
beta-carotene fi ndings and also found good evidence that vitamin E
does not protect against cancer or cardiovascular disease.
In response to the review industry trade associations offered
their analysis.
Cancer is a complex disease and the fact that there is even
some albeit limited evidence that a simple multivitamin could
prevent cancer demonstrates promise and should give consumers
added incentive to keep taking their multivitamins said Duffy
MacKay ND vice president scientifi c and regulatory affairs Council
for Responsible Nutrition (CRN) Washington D.C. We believe
the paucity of clinical trial evidence should not be misinterpreted as
a lack of benefi t for the multivitamin. We know for sure that multivitamins
can fi ll nutrient gaps and as so many people are not even
reaching the recommended dietary allowances for many nutrients
thats reason enough to add an affordable
and convenient multivitamin to their diets.
Further given the encouraging results
from the Physicians Health Study (PHS) II
(Gaziano et al 2012)the study referenced in
this report as demonstrating benefi t for multivitamins
and cancer risk in menacademics
and government as well as our own industry
should continue to support and fund research
to clarify this relationship and to determine additional
benefi ts for vitamins and other dietary supplements.
Cara Welch PhD senior vice president of scientifi c and regulatory
affairs noted the scope of this recent research has its limitations.
The meta-analysis focused on studies that researched
generally healthy people avoiding any instances for targeted
use of nutrients. Additionally the researchers only concentrated
on studies with vitamins and mineral supplements as the primary
source of prevention. Multivitamin supplements should not
be expected without the combination of a healthy lifestyle to
prevent chronic disease. The results of this review should not
lead to widespread concern among consumers who take vitamin
and mineral supplements.
John Shaw executive director NPA added Dietary supplements
are used by more than 150 million Americans on a daily
basis. Research has shown that when taken in combination with
other healthy lifestyle practices such as consuming a wholesome
diet and exercising regularly people can benefi t from dietary supplements.
Consumers should be comfortable following a variety of
healthy habits which includes supplementation. As always NPA
encourages consumers to speak with their healthcare professionals
regarding their dietary supplement regimen.
More than 150 million Americans use dietary
supplements on a daily basis.
16-31IndustryNews1213.indd 18 11/26/13 3:40 PM
Copyright of Nutraceuticals World is the property of Rodman Publishing and its content may
not be copied or emailed to multiple sites or posted to a listserv without the copyright holder’s
express written permission. However users may print download or email articles for
individual use.
The requirements below must be met for your paper to be accepted and graded:
Write between 750 1250 words (approximately 3 5 pages) using Microsoft Word in APA style see example below.
Use font size 12 and 1 margins.
Include cover page and reference page.
At least 80% of your paper must be original content/writing.
No more than 20% of your content/information may come from references.
Use at least three references from outside the course material one reference must be from EBSCOhost. Text book lectures and other materials in the course may be used but are not counted toward the three reference requirement.
Cite all reference material (data dates graphs quotes paraphrased words values etc.) in the paper and list on a reference page in APA style.